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The Economic Times

No observations by US FDA during plant inspection: DRL

Dr. Reddy's Laboratories announced that the U.S. Food & Drug Administration (FDA) completed a routine Good Manufacturing Practice (GMP) inspection of its integrated product development organization in Bachupally, Hyderabad, with zero observations. The company shared this update in a stock exchange filing on Friday, highlighting compliance with regulatory standards.

CNBC TV18

US FDA has no adverse observations after scan of Dr Reddy's Hyderabad R&D unit

The United States Food & Drug Administration (FDA) did a routine Good Manufacturing Practice (GMP) inspection at Dr Reddy's integrated product development organisation in Bachupally, Hyderabad. Shares of Dr Reddy's Laboratories Ltd ended at ₹6,552.50, up by ₹45.70, or 0.70%, on the BSE.

The Economic Times

Dr. Reddy's Laboratories Share Price Today Live Updates: Dr. Reddy's Laboratories Closes at Rs 6,567.80 with 10.27% Returns Over Three Months

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The Economic Times

Dr. Reddy's Laboratories Share Price Today Live Updates: Dr. Reddy's Laboratories Sees Minor Decline as Current Price Hits Rs 6599.10

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The Economic Times

Dr. Reddy's Laboratories Share Price Live Updates: Dr. Reddy's Laboratories Closes at Rs 6660.70 with Diminished Trading Volume

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Mint

Dr Reddy's denies Congress' claim of conflict in payments to SEBI chief Madhabi Buch's husband Dhaval

In a stock filing, Dr Reddy's Laboratories acknowledged payments to Dhaval Buch for coaching services but rejected conflict of interest claims.

The Economic Times

Dr Reddy's issues clarification after Congress alleges company benefited from Dhaval Buch connection, terms allegations 'baseless and malafide'

Dr Reddy's Laboratories has refuted allegations by the Indian National Congress that it benefited from its association with SEBI chairperson Madhabi Puri Buch's husband, Dhaval Buch. The company clarified that Dhaval Buch's engagement ended before Madhabi Buch became SEBI Chairperson and emphasized compliance with all laws. Dhaval Buch was hired for leadership coaching from October 2020 to April 2021, receiving remuneration in line with industry standards.

Business Standard

Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant

Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement. As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility. Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.

CNBC TV18

Dr Reddy’s Labs gets VAI classification for Andhra Pradesh facility from USFDA

Dr Reddy's Laboratories Share Price | The inspection has been classified as "Voluntary Action Indicated" (VAI) by the US drug regulator, meaning that while some minor issues were identified, no serious violations were found.

The Economic Times

Dr Reddy's, Lupin recall products in US due to manufacturing issues

Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, according to the USFDA. Dr Reddy's is recalling Ibuprofen tablets for failing impurity specifications, while Lupin is recalling Cefixime for Oral Suspension due to subpotency. Both recalls are classified as Class II, indicating potential temporary or medically reversible adverse health consequences.

Mint

Buy or sell: Sumeet Bagadia recommends three stocks to buy on Monday — Sept 2

Buy or sell stocks: Sumeet Bagadia has recommended three stocks to buy on Monday — Dr Reddy's Laboratories, Godrej Consumer Products, and Pidilite Industries

Business Standard

DRL's Andhra Pradesh facility gets 3 observations from USFDA

Dr Reddy's Laboratories said that the US drug regulator has issued Form 483, with three observations after inspecting its Andhra Pradesh manufacturing facility.

The Economic Times

Dr Reddy's gets establishment inspection report from USFDA for Visakhapatnam units

Dr Reddy's Laboratories Ltd has obtained an Establishment Inspection Report from the USFDA for its Duvvada units, now classified as Voluntary Action Indicated. The units underwent an inspection from May 8 to May 17, 2024, which led to a Form 483 with observations. Dr Reddy’s planned to resolve the issues within the given time.

Business Standard

Dr Reddy's, Sun Pharma recall drugs in US due to production issues: USFDA

Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the

Business Standard

Zydus and Dr Reddy's ink licensing agreement to co-market Pertuzumab in India

Zydus Lifesciences and Dr. Reddy's Laboratories announced the execution of a licensing agreement to co-market Pertuzumab biosimilar in India.